S.3002 would require dietary supplement manufacturers to register with the FDA and to notify the FDA of all ingredients that go into a particular supplement. The legislation responds to a GAO report recommendation from January 2009 (which shows you how fast things move in Washington) that stated that the FDA's oversight of supplements should be enhanced by requiring manufacturers to "(1) identify themselves as a dietary supplement company as part of the existing registration requirements and update this information annually, (2) provide a list of all dietary supplement products they sell and a copy of the labels and update this information annually, and (3) report all adverse events related to dietary supplements." The proposed legislation not only seeks to accomplish this, but would also give FDA mandatory recall authority.

Yesterday's posting at Eye on FDA carried a news item regarding an action by the U.S. Attorney's office out of the Western District of Missouri where a person entered a guilty plea regarding the operation of several Internet sites was able to accomplish $12 million in sales over a period of a few years selling dietary supplements for particular ailments under the claim that they had been clinically tested when, in fact, they had not.

Opponents of regulation have already been logging postings in blogs stating that this proposed legislation would threaten access to people's supplements. At a time when people are overly sensitive to the role of government, would this legislation be perceived as another encroachment by government? Or, is this an example where the elusive bipartisanship could actually see some light of day. Time and circumstances would favor the latter, though in today's political environment, that is no certainty.

A link to S.3002 has been added to the blog's Proposed Legislation List and you can follow the progress of the legislation at OpenCongress.

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About This Blog

Eye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.